Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06061458
Status:
UNKNOWN
Last Update Posted:
2023-10-03
First Post:
2023-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Children by Speech ABR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-30', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-24', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'speech process in the groups', 'timeFrame': '30 minutes after the test', 'description': 'presence of the waves in the test traces'}], 'secondaryOutcomes': [{'measure': 'best hearing amplification device', 'timeFrame': '30 minutes after the test', 'description': 'best waves of the test traces'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Impaired Children']}, 'referencesModule': {'references': [{'pmid': '36651959', 'type': 'RESULT', 'citation': 'Basoz Behmen M, Guler N, Kuru E, Bal N, Gedik Toker O. Speech auditory brainstem response in audiological practice: a systematic review. Eur Arch Otorhinolaryngol. 2023 May;280(5):2099-2118. doi: 10.1007/s00405-023-07830-3. Epub 2023 Jan 18.'}, {'pmid': '20121865', 'type': 'RESULT', 'citation': 'Basu M, Krishnan A, Weber-Fox C. Brainstem correlates of temporal auditory processing in children with specific language impairment. Dev Sci. 2010 Jan 1;13(1):77-91. doi: 10.1111/j.1467-7687.2009.00849.x.'}, {'pmid': '10862922', 'type': 'RESULT', 'citation': 'Walch C, Anderhuber W, Kole W, Berghold A. Bilateral sensorineural hearing disorders in children: etiology of deafness and evaluation of hearing tests. Int J Pediatr Otorhinolaryngol. 2000 Jun 9;53(1):31-8. doi: 10.1016/s0165-5876(00)00307-4.'}, {'pmid': '20084007', 'type': 'RESULT', 'citation': 'Skoe E, Kraus N. Auditory brain stem response to complex sounds: a tutorial. Ear Hear. 2010 Jun;31(3):302-24. doi: 10.1097/AUD.0b013e3181cdb272.'}, {'pmid': '18400899', 'type': 'RESULT', 'citation': 'Johnson KL, Nicol T, Zecker SG, Kraus N. Developmental plasticity in the human auditory brainstem. J Neurosci. 2008 Apr 9;28(15):4000-7. doi: 10.1523/JNEUROSCI.0012-08.2008.'}, {'pmid': '34535280', 'type': 'RESULT', 'citation': 'Hood LJ. Auditory Neuropathy/Auditory Synaptopathy. Otolaryngol Clin North Am. 2021 Dec;54(6):1093-1100. doi: 10.1016/j.otc.2021.07.004. Epub 2021 Sep 15.'}, {'pmid': '7782180', 'type': 'RESULT', 'citation': "Davis A, Fortnum H, O'Donoghue G. Children who could benefit from a cochlear implant: a European estimate of projected numbers, cost and relevant characteristics. Int J Pediatr Otorhinolaryngol. 1995 Mar;31(2-3):221-33. doi: 10.1016/0165-5876(94)01115-e."}]}, 'descriptionModule': {'briefSummary': 'Assessment of children by speech auditory brainstem response which is an objective method to study the speech development', 'detailedDescription': 'Hearing loss in children can result in cognitive deficits in the central areas which are dependent upon hearing, therefore responsible for delay in speech development, poor language skills and disorders in psychological and mental behavior. It will also cause a decrease of the intellectual ability and socio-economic position of the child.\n\nIn children aged 3.5 years and older, pure tone audiometry is performed to determine the exact frequency-specific hearing threshold.\n\nTo obtain the auditory threshold in younger children, Skoe and Kraus reported that the auditory brainstem response has proven to be a clinically useful tool for assessing neural function at the brainstem level and is most commonly elicited by clicks or tone-bursts.\n\nHowever, recent research has established that complex stimuli can also elicit the response such as Music, complex tones, and speech stimuli . A speech stimulus is particularly useful, as it can provide clues as to how temporal and spectral features are preserved in the brainstem.\n\nThe human soundscape is characterized by complex sounds with rich harmonic structure, dynamic amplitude modulations and rapid spectro-temporal fluctuations. This complexity is represented by temporal and spectral neural code within the auditory brainstem, two broad classes of time-locked responses can be defined namely transient and sustained responses .\n\nAlthough complex sounds consist of both sustained and transient features, the response to a complex sound is not necessarily predictable from the response to click auditory brainstem response . For these reason, further studies had gradually transitioned to using sounds as stimuli as they are more complex .\n\nThe click auditory brainstem response is a clinical tool to assess the neural functionality of the auditory brainstem. The use of verbal stimuli in auditory brainstem response protocols has provided important information of how the speech stimuli are processed by the brainstem structure .\n\nThe perception of speech sounds seems to begin in the brainstem, which has an important role in the reading process and the phonological acquisition . Speech auditory brainstem response assessment allows the identification of fine-grained auditory processing deficits associated with real world communication which do not appear in click evoked auditory brainstem response .\n\nThe verbal stimulus most widely used in speech auditory brainstem response is a syllable composed of a consonant and a vowel , usually the syllables da. The verbal assessment provides information about how the speech syllable is encoded by auditory system. The trace of the speech auditory brainstem response can be identified in two parts:\n\nThe onset and the frequency following response . The first part represents the consonant and the second part represents the vowel .\n\nSo speech auditory brainstem response can be used as an objective measure of the hearing function, one of the great advantages of this method is that it is not influenced by environmental issues, which can disrupt the behavioral assessments . Even the best behavioral tests can be affected by multiple factors such as attention, motivation and alertness or fatigue .\n\nMoreover, altered responses of speech auditory brainstem response may be associated with impaired speech perception specially in noise. These changes can cause a negative impact on communication and serious consequences for academic success in children. complex auditory brainstem response can also help to identify those individuals who are most likely to benefit from auditory training .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Control group: (25) Children with normal peripheral hearing bilaterally their age is matched with the study group.\n* Study group: three study groups, each study group has (25) children using, binaural Hearing aids, Cochlear implant and bimodal hearing with:\n* Average IQ.\n* No other congenital diseases affecting the speech progress.\n* Using the hearing device for at least one year.\n* Regular speech therapy sessions\n\nExclusion Criteria:\n\n• Any other children not fulfilling the inclusion criteria or refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06061458', 'briefTitle': 'Assessment of Children by Speech ABR', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Children With Variable Hearing Amplification Devices by Speech Auditory Brainstem Response', 'orgStudyIdInfo': {'id': 'ACDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'normal hearing'}, {'type': 'EXPERIMENTAL', 'label': 'the group with hearing aids', 'description': 'children with hearing aids', 'interventionNames': ['Diagnostic Test: speech auditory brainstem response']}, {'type': 'EXPERIMENTAL', 'label': 'the group with cochlear implant', 'description': 'children with cochlear implant', 'interventionNames': ['Diagnostic Test: speech auditory brainstem response']}, {'type': 'EXPERIMENTAL', 'label': 'the group with bimodal hearing', 'description': 'children with bimodal hearing', 'interventionNames': ['Diagnostic Test: speech auditory brainstem response']}], 'interventions': [{'name': 'speech auditory brainstem response', 'type': 'DIAGNOSTIC_TEST', 'description': 'A diagnostic objective test to evaluate the speech process in hearing impaired children', 'armGroupLabels': ['the group with bimodal hearing', 'the group with cochlear implant', 'the group with hearing aids']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amal Mohamed, professor', 'role': 'CONTACT', 'email': 'amalelattar99@yahoo.com', 'phone': '01003676677'}, {'name': 'Enas Moustafa, lecturer', 'role': 'CONTACT', 'email': 'Enasosman101@gmail.com', 'phone': '01061121765'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'kholoud omar, MD', 'investigatorAffiliation': 'Assiut University'}}}}